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2.
JAMA ; 326(17): 1703-1712, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1525396

ABSTRACT

Importance: Acutely ill inpatients with COVID-19 typically receive antithrombotic therapy, although the risks and benefits of this intervention among outpatients with COVID-19 have not been established. Objective: To assess whether anticoagulant or antiplatelet therapy can safely reduce major adverse cardiopulmonary outcomes among symptomatic but clinically stable outpatients with COVID-19. Design, Setting, and Participants: The ACTIV-4B Outpatient Thrombosis Prevention Trial was designed as a minimal-contact, adaptive, randomized, double-blind, placebo-controlled trial to compare anticoagulant and antiplatelet therapy among 7000 symptomatic but clinically stable outpatients with COVID-19. The trial was conducted at 52 US sites between September 2020 and June 2021; final follow-up was August 5, 2021. Prior to initiating treatment, participants were required to have platelet count greater than 100 000/mm3 and estimated glomerular filtration rate greater than 30 mL/min/1.73 m2. Interventions: Random allocation in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days. Main Outcomes and Measures: The primary end point was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause. The primary analyses for efficacy and bleeding events were limited to participants who took at least 1 dose of trial medication. Results: On June 18, 2021, the trial data and safety monitoring board recommended early termination because of lower than anticipated event rates; at that time, 657 symptomatic outpatients with COVID-19 had been randomized (median age, 54 years [IQR, 46-59]; 59% women). The median times from diagnosis to randomization and from randomization to initiation of study treatment were 7 days and 3 days, respectively. Twenty-two randomized participants (3.3%) were hospitalized for COVID-19 prior to initiating treatment. Among the 558 patients who initiated treatment, the adjudicated primary composite end point occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5-mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group. The risk differences compared with placebo for the primary end point were 0.0% (95% CI not calculable) in the aspirin group, 0.7% (95% CI, -2.1% to 4.1%) in the 2.5-mg apixaban group, and 1.4% (95% CI, -1.5% to 5.0%) in the 5-mg apixaban group. Risk differences compared with placebo for bleeding events were 2.0% (95% CI, -2.7% to 6.8%), 4.5% (95% CI, -0.7% to 10.2%), and 6.9% (95% CI, 1.4% to 12.9%) among participants who initiated therapy in the aspirin, prophylactic apixaban, and therapeutic apixaban groups, respectively, although none were major. Findings inclusive of all randomized patients were similar. Conclusions and Relevance: Among symptomatic clinically stable outpatients with COVID-19, treatment with aspirin or apixaban compared with placebo did not reduce the rate of a composite clinical outcome. However, the study was terminated after enrollment of 9% of participants because of an event rate lower than anticipated. Trial Registration: ClinicalTrials.gov Identifier: NCT04498273.


Subject(s)
Aspirin/therapeutic use , COVID-19/drug therapy , Factor Xa Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Pyrazoles/therapeutic use , Pyridones/therapeutic use , Thrombosis/prevention & control , Adult , Aspirin/adverse effects , COVID-19/complications , Dose-Response Relationship, Drug , Double-Blind Method , Early Termination of Clinical Trials , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/adverse effects , Female , Hemorrhage/chemically induced , Hospitalization , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/adverse effects , Pyrazoles/administration & dosage , Pyrazoles/adverse effects , Pyridones/administration & dosage , Pyridones/adverse effects
3.
Turk J Med Sci ; 51(4): 1653-1658, 2021 08 30.
Article in English | MEDLINE | ID: covidwho-1526880

ABSTRACT

Background/aim: COVID-19 has now become a global pandemic. Understanding the routes of transmission is vital in the mitigation and suppression of the disease. Istanbul has become one of the disease's epicenters. This study aims to describe the first COVID-19 case and contact tracing efforts around it in Istanbul. Materials and methods: The descriptive study was conducted in Istanbul, Turkey. The first COVID-19 cases and those associated with them were investigated with contact tracing, and primary and secondary cases were described. Results: The source case was an individual who returned to Turkey from international travel at the beginning of March and tested PCR (­). The index case is the brother of the source case and is considered the first PCR (+) case diagnosed in Istanbul. Contact tracing revealed 23 PCR (+) cases, 14 of which resulted in hospitalization and three deaths. Conclusions: This study described cases of the first COVID-19 cluster in Istanbul. Moreover, contact tracing was used in this first cluster. This contributed to contact tracing algorithms in Turkey.


Subject(s)
COVID-19/transmission , Contact Tracing/methods , Hospitalization/statistics & numerical data , Adult , Aged , Female , Humans , Male , Middle Aged , SARS-CoV-2 , Turkey , Young Adult
4.
PLoS One ; 16(10): e0257892, 2021.
Article in English | MEDLINE | ID: covidwho-1526682

ABSTRACT

BACKGROUND: Coronavirus Disease 2019 (COVID-19) is a respiratory viral illness causing pneumonia and systemic disease. Abnormalities in pulmonary function tests (PFT) after COVID-19 infection have been described. The determinants of these abnormalities are unclear. We hypothesized that inflammatory biomarkers and CT scan parameters at the time of infection would be associated with abnormal gas transfer at short term follow-up. METHODS: We retrospectively studied subjects who were hospitalized for COVID-19 pneumonia and discharged. Serum inflammatory biomarkers, CT scan and clinical characteristics were assessed. CT images were evaluated by Functional Respiratory Imaging with automated tissue segmentation algorithms of the lungs and pulmonary vasculature. Volumes of the pulmonary vessels that were ≤5mm (BV5), 5-10mm (BV5_10), and ≥10mm (BV10) in cross sectional area were analyzed. Also the amount of opacification on CT (ground glass opacities). PFT were performed 2-3 months after discharge. The diffusion capacity of carbon monoxide (DLCO) was obtained. We divided subjects into those with a DLCO <80% predicted (Low DLCO) and those with a DLCO ≥80% predicted (Normal DLCO). RESULTS: 38 subjects were included in our cohort. 31 out of 38 (81.6%) subjects had a DLCO<80% predicted. The groups were similar in terms of demographics, body mass index, comorbidities, and smoking status. Hemoglobin, inflammatory biomarkers, spirometry and lung volumes were similar between groups. CT opacification and BV5 were not different between groups, but both Low and Normal DLCO groups had lower BV5 measures compared to healthy controls. BV5_10 and BV10 measures were higher in the Low DLCO group compared to the normal DLCO group. Both BV5_10 and BV10 in the Low DLCO group were greater compared to healthy controls. BV5_10 was independently associated with DLCO<80% in multivariable logistic regression (OR 1.29, 95% CI 1.01, 1.64). BV10 negatively correlated with DLCO% predicted (r = -0.343, p = 0.035). CONCLUSIONS: Abnormalities in pulmonary vascular volumes at the time of hospitalization are independently associated with a low DLCO at follow-up. There was no relationship between inflammatory biomarkers during hospitalization and DLCO. Pulmonary vascular abnormalities during hospitalization for COVID-19 may serve as a biomarker for abnormal gas transfer after COVID-19 pneumonia.


Subject(s)
COVID-19/diagnostic imaging , Lung/blood supply , Lung/diagnostic imaging , SARS-CoV-2/metabolism , Tomography, X-Ray Computed , Adult , Aged , Biomarkers/metabolism , COVID-19/metabolism , COVID-19/therapy , Female , Follow-Up Studies , Hospitalization , Humans , Lung/metabolism , Lung/virology , Male , Middle Aged , Retrospective Studies
6.
Blood Coagul Fibrinolysis ; 32(8): 544-549, 2021 Dec 01.
Article in English | MEDLINE | ID: covidwho-1526211

ABSTRACT

Standard biomarkers have been widely used for COVID-19 diagnosis and prognosis. We hypothesize that thrombogenicity metrics measured by thromboelastography will provide better diagnostic and prognostic utility versus standard biomarkers in COVID-19 positive patients. In this observational prospective study, we included 119 hospitalized COVID-19 positive patients and 15 COVID-19 negative patients. On admission, we measured standard biomarkers and thrombogenicity using a novel thromboelastography assay (TEG-6s). In-hospital all-cause death and thrombotic occurrences (thromboembolism, myocardial infarction and stroke) were recorded. Most COVID-19 patients were African--Americans (68%). COVID-19 patients versus COVID-19 negative patients had higher platelet-fibrin clot strength (P-FCS), fibrin clot strength (FCS) and functional fibrinogen level (FLEV) (P ≤ 0.003 for all). The presence of high TEG-6 s metrics better discriminated COVID-19 positive from negative patients. COVID-19 positive patients with sequential organ failure assessment (SOFA) score at least 3 had higher P-FCS, FCS and FLEV than patients with scores less than 3 (P ≤ 0.001 for all comparisons). By multivariate analysis, the in-hospital composite endpoint occurrence of death and thrombotic events was independently associated with SOFA score more than 3 [odds ratio (OR) = 2.9, P = 0.03], diabetes (OR = 3.3, P = 0.02) and FCS > 40 mm (OR = 3.4, P = 0.02). This largest observational study suggested the early diagnostic and prognostic utility of thromboelastography to identify COVID-19 and should be considered hypothesis generating. Our results also support the recent FDA guidance regarding the importance of measurement of whole blood viscoelastic properties in COVID-19 patients. Our findings are consistent with the observation of higher hospitalization rates and poorer outcomes for African--Americans with COVID-19.


Subject(s)
COVID-19/blood , SARS-CoV-2 , Thrombophilia/diagnosis , Adult , African Americans/statistics & numerical data , Aged , Aged, 80 and over , Biomarkers , COVID-19/complications , COVID-19/epidemiology , COVID-19 Testing , Cardiovascular Diseases/epidemiology , Comorbidity , Diabetes Mellitus/epidemiology , Early Diagnosis , European Continental Ancestry Group/statistics & numerical data , Female , Fibrin/analysis , Fibrin Clot Lysis Time , Fibrinogen/analysis , Hospitalization , Humans , Hyperlipidemias/epidemiology , L-Lactate Dehydrogenase/blood , Male , Middle Aged , Obesity/epidemiology , Organ Dysfunction Scores , Prognosis , Prospective Studies , Thrombelastography , Thrombophilia/blood , Thrombophilia/drug therapy , Thrombophilia/etiology , Treatment Outcome
7.
Epidemiol Prev ; 45: In press, 2021.
Article in English | MEDLINE | ID: covidwho-1524743

ABSTRACT

BACKGROUND: since the beginning of the COVID-19 pandemic, specific characteristics of the infected subjects appeared to be associated with a severe disease, leading to hospitalization or death. OBJECTIVES: to evaluate the association between three components of the metabolic syndrome (diabetes mellitus, dyslipidaemia, and hypertension), alone and in combination, and risk of hospitalization in subjects with nasopharyngeal swab-confirmed COVID-19. DESIGN: cohort study. SETTING AND PARTICIPANTS: the study subjects were all COVID-19 cases diagnosed in the area of the Agency for Health Protection of the Metropolitan Area of Milan (Lombardy Region, Northern Italy) between 10.02.2020 and 25.04.2020, whose data were gathered with an ad hoc information system developed at the beginning of the pandemic. MAIN OUTCOME MEASURES: the association between metabolic syndrome components (alone and in combination) and hospitalization (both in any ward and in intensive care unit) was measured by means of cause-specific Cox models with gender, age, and comorbidities as potential confounders. RESULTS: the cohort included 15,162 subjects followed from diagnosis up to 20.07.2020. Adjusted hazard ratios (HRs) of hospitalization in any ward estimated by the Cox model were 1.26 for uncomplicated diabetes mellitus (95%CI 1.18-1.34); 1.21 for complicated diabetes mellitus (95%CI 1.05-1.39); 1.07 for dyslipidaemia (95%CI 1.00-1.14); and 1.11 for hypertension (95%CI 1.05-1.17). When all components coexisted in the same subject, the HR was 1.46 (95%CI 1.31-1.62). A significant increase in risk of hospitalization in intensive care unit was found for uncomplicated diabetes mellitus (HR 1.38; 95%CI 1.15-1.66). CONCLUSIONS: this population-based study confirms that metabolic syndrome components increase the risk of hospitalization for COVID-19. The HR increases in an additive manner when the three components are simultaneously present.


Subject(s)
COVID-19 , Metabolic Syndrome , Cohort Studies , Comorbidity , Hospitalization , Humans , Italy/epidemiology , Metabolic Syndrome/epidemiology , Pandemics , SARS-CoV-2
8.
MMWR Morb Mortal Wkly Rep ; 70(46): 1608-1612, 2021 Nov 19.
Article in English | MEDLINE | ID: covidwho-1524680

ABSTRACT

Population-based rates of infection with SARS-CoV-2 (the virus that causes COVID-19) and related health care utilization help determine estimates of COVID-19 vaccine effectiveness and averted illnesses, especially since the SARS-CoV-2 B.1.617.2 (Delta) variant began circulating in June 2021. Among members aged ≥12 years of a large integrated health care delivery system in Oregon and Washington, incidence of laboratory-confirmed SARS-CoV-2 infection, emergency department (ED) visits, and hospitalizations were calculated by COVID-19 vaccination status, vaccine product, age, race, and ethnicity. Infection after full vaccination was defined as a positive SARS-CoV-2 molecular test result ≥14 days after completion of an authorized COVID-19 vaccination series.* During the July-September 2021 surveillance period, SARS-CoV-2 infection occurred among 4,146 of 137,616 unvaccinated persons (30.1 per 1,000 persons) and 3,009 of 344,848 fully vaccinated persons (8.7 per 1,000). Incidence was higher among unvaccinated persons than among vaccinated persons across all demographic strata. Unvaccinated persons with SARS-CoV-2 infection were more than twice as likely to receive ED care (18.5%) or to be hospitalized (9.0%) than were vaccinated persons with COVID-19 (8.1% and 3.9%, respectively). The crude mortality rate was also higher among unvaccinated patients (0.43 per 1,000) than in fully vaccinated patients (0.06 per 1,000). These data support CDC recommendations for COVID-19 vaccination, including additional and booster doses, to protect individual persons and communities against COVID-19, including illness and hospitalization caused by the Delta variant (1).


Subject(s)
COVID-19/epidemiology , COVID-19/therapy , Emergency Service, Hospital/statistics & numerical data , Hospitalization/statistics & numerical data , Adolescent , Adult , Aged , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , Child , Female , Humans , Incidence , Male , Middle Aged , Oregon/epidemiology , Vaccination/statistics & numerical data , Washington/epidemiology , Young Adult
10.
Rev Rene (Online) ; 22: e61049, 2021. tab
Article in Portuguese | LILACS (Americas) | ID: covidwho-1518833

ABSTRACT

RESUMO Objetivo analisar o tempo de permanência hospitalar e status das primeiras internações por COVID-19 em mulheres no início da pandemia. Métodos estudo ecológico com dados das internações por COVID-19 em mulheres. Os dados foram estratificados por estados, regiões, idade, tempo de permanência hospitalar, diagnóstico principal e secundários (comorbidades) e desfecho da internação. Utilizaram-se os testes de Kruskall-Wallis, Mann-Whitney e qui-quadrado para a análise. Resultados a região Sudeste teve o maior número de internações (0,6%). Do total de internações, 14,6% necessitaram de unidade intensiva. O tempo de permanência hospitalar em mulheres acima de 50 anos foi significativo para o Brasil (p<0,001). Houve associação entre tempo de permanência hospitalar e níveis 2 e 3 de comorbidade. Óbitos em mulheres com mais de 50 anos foi significativo no Brasil, Nordeste e Sudeste (p<0,001). Conclusão mulheres com mais de 50 anos e com comorbidades estão associadas ao maior tempo de internação hospitalar e óbitos.


ABSTRACT Objective to analyze the length of hospital stay and outcomes of the first hospitalizations due to COVID-19 of women at the beginning of the pandemic. Methods ecological study with data on COVID-19 hospitalizations of women. Data classification was done by states, regions, age, length of hospital stay, main and secondary diagnosis (underlying diseases), and outcome. Kruskal-Wallis, Mann-Whitney, and chi-square tests were used for the analysis. Results the Southeast region had the highest number of hospitalizations (0.6%). Of the total number of hospitalizations, 14.6% required an intensive care unit. The length of hospital stay of women over 50 years was significant for Brazil (p<0.001). There was an association between length of hospital stay and levels 2 and 3 of comorbidity. Deaths in women over 50 years old were significant in Brazil, Northeast, and Southeast (p<0.001). Conclusion women over 50 years old with comorbidities are associated with longer hospital stays and deaths.


Subject(s)
Women , Coronavirus Infections , Hospitalization , Intensive Care Units , Length of Stay
11.
Ann Intern Med ; 174(1): JC3, 2021 01.
Article in English | MEDLINE | ID: covidwho-1518748

ABSTRACT

SOURCE CITATION: RECOVERY Collaborative Group. Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2020;396:1345-52. 33031764.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Hospitalization , Lopinavir/therapeutic use , Ritonavir/therapeutic use , Administration, Oral , Aged , Antiviral Agents/administration & dosage , COVID-19/mortality , Drug Combinations , Female , Humans , Lopinavir/administration & dosage , Male , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Ritonavir/administration & dosage , SARS-CoV-2 , United Kingdom
12.
Front Immunol ; 12: 765330, 2021.
Article in English | MEDLINE | ID: covidwho-1518489

ABSTRACT

Aims: Although the exact factors promoting disease progression in COVID-19 are not fully elucidated, unregulated activation of the complement system (CS) seems to play a crucial role in the pathogenesis of acute lung injury (ALI) induced by SARS-CoV-2. In particular, the lectin pathway (LP) has been implicated in previous autopsy studies. The primary purpose of our study is to investigate the role of the CS in hospitalized COVID-19 patients with varying degrees of disease severity. Methods: In a single-center prospective observational study, 154 hospitalized patients with PCR-confirmed SARS-CoV-2 infection were included. Serum samples on admission to the COVID-19 ward were collected for analysis of CS pathway activities and concentrations of LP proteins [mannose-binding lectin (MBL) and ficolin-3 (FCN-3)] & C1 esterase inhibitor (C1IHN). The primary outcome was mechanical ventilation or in-hospital death. Results: The patients were predominately male and had multiple comorbidities. ICU admission was required in 16% of the patients and death (3%) or mechanical ventilation occurred in 23 patients (15%). There was no significant difference in LP activity, MBL and FCN-3 concentrations according to different peak disease severities. The median alternative pathway (AP) activity was significantly lower (65%, IQR 50-94) in patients with death/invasive ventilation compared to patients without (87%, IQR 68-102, p=0.026). An optimal threshold of <65.5% for AP activity was derived from a ROC curve resulting in increased odds for death or mechanical ventilation (OR 4,93; 95% CI 1.70-14.33, p=0.003) even after adjustment for confounding factors. Classical pathway (CP) activity was slightly lower in patients with more severe disease (median 101% for death/mechanical ventilation vs 109%, p=0.014). C1INH concentration correlated positively with length of stay, inflammatory markers and disease severity on admission but not during follow-up. Conclusion: Our results point to an overactivated AP in critically ill COVID-19 patients in vivo leading to complement consumption and consequently to a significantly reduced AP activity in vitro. The LP does not seem to play a role in the progression to severe COVID-19. Apart from its acute phase reaction the significance of C1INH in COVID-19 requires further studies.


Subject(s)
COVID-19/immunology , Complement System Proteins/immunology , SARS-CoV-2 , Adult , Aged , COVID-19/blood , COVID-19/mortality , COVID-19/therapy , Complement C1 Inhibitor Protein/immunology , Critical Illness , Female , Hospital Mortality , Hospitalization , Humans , Lectins/immunology , Male , Middle Aged , Prospective Studies , Respiration, Artificial , Severity of Illness Index
13.
JMIR Public Health Surveill ; 7(11): e29504, 2021 11 15.
Article in English | MEDLINE | ID: covidwho-1518435

ABSTRACT

BACKGROUND: The COVID-19 pandemic has placed a huge strain on the health care system globally. The metropolitan area of Milan, Italy, was one of the regions most impacted by the COVID-19 pandemic worldwide. Risk prediction models developed by combining administrative databases and basic clinical data are needed to stratify individual patient risk for public health purposes. OBJECTIVE: This study aims to develop a stratification tool aimed at improving COVID-19 patient management and health care organization. METHODS: A predictive algorithm was developed and applied to 36,834 patients with COVID-19 in Italy between March 8 and the October 9, 2020, in order to foresee their risk of hospitalization. Exposures considered were age, sex, comorbidities, and symptoms associated with COVID-19 (eg, vomiting, cough, fever, diarrhea, myalgia, asthenia, headache, anosmia, ageusia, and dyspnea). The outcome was hospitalizations and emergency department admissions for COVID-19. Discrimination and calibration of the model were also assessed. RESULTS: The predictive model showed a good fit for predicting COVID-19 hospitalization (C-index 0.79) and a good overall prediction accuracy (Brier score 0.14). The model was well calibrated (intercept -0.0028, slope 0.9970). Based on these results, 118,804 patients diagnosed with COVID-19 from October 25 to December 11, 2020, were stratified into low, medium, and high risk for COVID-19 severity. Among the overall study population, 67,030 (56.42%) were classified as low-risk patients; 43,886 (36.94%), as medium-risk patients; and 7888 (6.64%), as high-risk patients. In all, 89.37% (106,179/118,804) of the overall study population was being assisted at home, 9% (10,695/118,804) was hospitalized, and 1.62% (1930/118,804) died. Among those assisted at home, most people (63,983/106,179, 60.26%) were classified as low risk, whereas only 3.63% (3858/106,179) were classified at high risk. According to ordinal logistic regression, the odds ratio (OR) of being hospitalized or dead was 5.0 (95% CI 4.6-5.4) among high-risk patients and 2.7 (95% CI 2.6-2.9) among medium-risk patients, as compared to low-risk patients. CONCLUSIONS: A simple monitoring system, based on primary care data sets linked to COVID-19 testing results, hospital admissions data, and death records may assist in the proper planning and allocation of patients and resources during the ongoing COVID-19 pandemic.


Subject(s)
COVID-19 , Algorithms , COVID-19 Testing , Hospitalization , Humans , Pandemics , SARS-CoV-2
14.
An Pediatr (Engl Ed) ; 95(5): 345-353, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1517028

ABSTRACT

INTRODUCTION: Non-pharmaceutical interventions that have been implemented in southern hemisphere countries because of COVID-19 pandemic declaration in March 2020, have evidenced some unexpected changes in the way of spreading of many other viruses. This study as a part of ECEALHBA's Project, reports the consequences of COVID-19 pandemic over 2020-2021 bronchiolitis epidemic period in the Central and Eastern regions of Spain. METHOD: Multicenter, observational, descriptive and ambispective study of admitted infants with the diagnosis of bronchiolitis in 16 Spanish hospitals involved in the investigation project. Five epidemic periods previous to COVID-19 pandemic, from 2015 to 2020, were compared with the current one, 2020-2021, in both a qualitative and quantitative manner. RESULTS: Total of 4643 infants were admitted to the participating hospitals along the study period. Pandemic season hospital admissions for bronchiolitis were 94.1% lower than in pre-pandemic period. December and January were peak months for bronchiolitis admissions during pre-pandemic period, but September was the peak month during pandemic year. There was a progressive decrease of admissions from this moment until the end of the follow-up, in April 2021. Rhinovirus has been the commonest etiology for bronchiolitis in 2020-2021 epidemic period of bronchiolitis. CONCLUSIONS: Some of the non-pharmaceutical interventions initiated because of COVID-19 pandemic are probably related to the dramatic decrease of bronchiolitis cases in 2020-2021 season. It would be rewarding to purpose novel research to clarify how these simple interventions can be useful, close to vaccines and antiviral drugs, to achieve the goal of avoiding the spread of respiratory viruses in pediatric population.


Subject(s)
Bronchiolitis , COVID-19 , Bronchiolitis/epidemiology , Child , Hospitalization , Humans , Infant , Pandemics , SARS-CoV-2 , Spain/epidemiology
15.
Ann Intern Med ; 174(10): 1409-1419, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1515633

ABSTRACT

BACKGROUND: The COVID-19 pandemic has caused substantial morbidity and mortality. OBJECTIVE: To describe monthly clinical trends among adults hospitalized with COVID-19. DESIGN: Pooled cross-sectional study. SETTING: 99 counties in 14 states participating in the Coronavirus Disease 2019-Associated Hospitalization Surveillance Network (COVID-NET). PATIENTS: U.S. adults (aged ≥18 years) hospitalized with laboratory-confirmed COVID-19 during 1 March to 31 December 2020. MEASUREMENTS: Monthly hospitalizations, intensive care unit (ICU) admissions, and in-hospital death rates per 100 000 persons in the population; monthly trends in weighted percentages of interventions, including ICU admission, mechanical ventilation, and vasopressor use, among an age- and site-stratified random sample of hospitalized case patients. RESULTS: Among 116 743 hospitalized adults with COVID-19, the median age was 62 years, 50.7% were male, and 40.8% were non-Hispanic White. Monthly rates of hospitalization (105.3 per 100 000 persons), ICU admission (20.2 per 100 000 persons), and death (11.7 per 100 000 persons) peaked during December 2020. Rates of all 3 outcomes were highest among adults aged 65 years or older, males, and Hispanic or non-Hispanic Black persons. Among 18 508 sampled hospitalized adults, use of remdesivir and systemic corticosteroids increased from 1.7% and 18.9%, respectively, in March to 53.8% and 74.2%, respectively, in December. Frequency of ICU admission, mechanical ventilation, and vasopressor use decreased from March (37.8%, 27.8%, and 22.7%, respectively) to December (20.5%, 12.3%, and 12.8%, respectively); use of noninvasive respiratory support increased from March to December. LIMITATION: COVID-NET covers approximately 10% of the U.S. population; findings may not be generalizable to the entire country. CONCLUSION: Rates of COVID-19-associated hospitalization, ICU admission, and death were highest in December 2020, corresponding with the third peak of the U.S. pandemic. The frequency of intensive interventions for management of hospitalized patients decreased over time. These data provide a longitudinal assessment of clinical trends among adults hospitalized with COVID-19 before widespread implementation of COVID-19 vaccines. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.


Subject(s)
COVID-19/therapy , Hospitalization/trends , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/therapeutic use , Adolescent , Adrenal Cortex Hormones/therapeutic use , Adult , Age Distribution , Aged , Alanine/analogs & derivatives , Alanine/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/ethnology , COVID-19/mortality , Critical Care/trends , Cross-Sectional Studies , Female , Humans , Intensive Care Units/trends , Length of Stay/trends , Male , Middle Aged , Pandemics , Respiration, Artificial/trends , SARS-CoV-2 , United States/epidemiology , Vasoconstrictor Agents/therapeutic use , Young Adult
16.
BMJ Open ; 11(11): e050202, 2021 11 11.
Article in English | MEDLINE | ID: covidwho-1515299

ABSTRACT

INTRODUCTION: Severe SARS-CoV-2 infection is associated with a dysregulated immune response. Inflammatory monocytes and macrophages are crucial, promoting injurious, proinflammatory sequelae. Immunomodulation is, therefore, an attractive therapeutic strategy and we sought to test licensed and novel candidate drugs. METHODS AND ANALYSIS: The CATALYST trial is a multiarm, open-label, multicentre, phase II platform trial designed to identify candidate novel treatments to improve outcomes of patients hospitalised with COVID-19 compared with usual care. Treatments with evidence of biomarker improvements will be put forward for larger-scale testing by current national phase III platform trials. Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40 mg/L are eligible. The primary outcome measure is CRP, measured serially from admission to day 14, hospital discharge or death. Secondary outcomes include the WHO Clinical Progression Improvement Scale as a principal efficacy assessment. ETHICS AND DISSEMINATION: The protocol was approved by the East Midlands-Nottingham 2 Research Ethics Committee (20/EM/0115) and given urgent public health status; initial approval was received on 5 May 2020, current protocol version (V.6.0) approval on 12 October 2020. The MHRA also approved all protocol versions. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBERS: EudraCT2020-001684-89, ISRCTN40580903.


Subject(s)
COVID-19 , Adult , Clinical Trials, Phase II as Topic , Hospitalization , Humans , Multicenter Studies as Topic , Research , SARS-CoV-2
19.
JAMA Netw Open ; 4(11): e2134241, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1508587

ABSTRACT

Importance: The influence of sleep-disordered breathing (SDB) and sleep-related hypoxemia in SARS-CoV-2 viral infection and COVID-19 outcomes remains unknown. Controversy exists regarding whether to continue treatment for SDB with positive airway pressure given concern for aerosolization with limited data to inform professional society recommendations. Objective: To investigate the association of SDB (identified via polysomnogram) and sleep-related hypoxia with (1) SARS-CoV-2 positivity and (2) World Health Organization (WHO)-designated COVID-19 clinical outcomes while accounting for confounding including obesity, underlying cardiopulmonary disease, cancer, and smoking history. Design, Setting, and Participants: This case-control study was conducted within the Cleveland Clinic Health System (Ohio and Florida) and included all patients who were tested for COVID-19 between March 8 and November 30, 2020, and who had an available sleep study record. Sleep indices and SARS-CoV-2 positivity were assessed with overlap propensity score weighting, and COVID-19 clinical outcomes were assessed using the institutional registry. Exposures: Sleep study-identified SDB (defined by frequency of apneas and hypopneas using the Apnea-Hypopnea Index [AHI]) and sleep-related hypoxemia (percentage of total sleep time at <90% oxygen saturation [TST <90]). Main Outcomes and Measures: Outcomes were SARS-CoV-2 infection and WHO-designated COVID-19 clinical outcomes (hospitalization, use of supplemental oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation, and death). Results: Of 350 710 individuals tested for SARS-CoV-2, 5402 (mean [SD] age, 56.4 [14.5] years; 3005 women [55.6%]) had a prior sleep study, of whom 1935 (35.8%) tested positive for SARS-CoV-2. Of the 5402 participants, 1696 were Black (31.4%), 3259 were White (60.3%), and 822 were of other race or ethnicity (15.2%). Patients who were positive vs negative for SARS-CoV-2 had a higher AHI score (median, 16.2 events/h [IQR, 6.1-39.5 events/h] vs 13.6 events/h [IQR, 5.5-33.6 events/h]; P < .001) and increased TST <90 (median, 1.8% sleep time [IQR, 0.10%-12.8% sleep time] vs 1.4% sleep time [IQR, 0.10%-10.8% sleep time]; P = .02). After overlap propensity score-weighted logistic regression, no SDB measures were associated with SARS-CoV-2 positivity. Median TST <90 was associated with the WHO-designated COVID-19 ordinal clinical outcome scale (adjusted odds ratio, 1.39; 95% CI, 1.10-1.74; P = .005). Time-to-event analyses showed sleep-related hypoxia associated with a 31% higher rate of hospitalization and mortality (adjusted hazard ratio, 1.31; 95% CI, 1.08-1.57; P = .005). Conclusions and Relevance: In this case-control study, SDB and sleep-related hypoxia were not associated with increased SARS-CoV-2 positivity; however, once patients were infected with SARS-CoV-2, sleep-related hypoxia was an associated risk factor for detrimental COVID-19 outcomes.


Subject(s)
COVID-19 , Cause of Death , Hospitalization , Severity of Illness Index , Sleep Apnea Syndromes/complications , Aged , COVID-19/complications , COVID-19/mortality , COVID-19/therapy , Case-Control Studies , Continuous Positive Airway Pressure , Delivery of Health Care, Integrated , Extracorporeal Membrane Oxygenation , Female , Florida , Hospital Mortality , Humans , Hypoxia , Logistic Models , Male , Middle Aged , Odds Ratio , Ohio , Respiration, Artificial , Risk Factors , SARS-CoV-2 , Sleep , Sleep Apnea Syndromes/pathology , Sleep Apnea Syndromes/therapy
20.
Saudi Med J ; 42(4): 370-376, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1513257

ABSTRACT

OBJECTIVES: To assess the neutrophil-to-lymphocyte ratio (NLR) diagnostic and prognostic value in the context of Coronavirus disease-2019 (COVID-19) infection in Saudi Arabia. METHODS: A case-control study in which 701 confirmed COVID-19 patients (of which 41 were intensive care unit [ICU]-admitted) and 250 control subjects were enrolled. The study was conducted retrospectively in October on patients admitted to 3 separate hospitals in Saudi Arabia namely: King Abdullah Bin Abdulaziz University Hospital (Riyadh), Ohud Hospital (Madinah), and Nojood Medical Center (Madinah) between May and September 2020. Neutrophil-to-lymphocyte ratio was calculated based on absolute neutrophil and lymphocyte count. Institutional ethical approval was obtained prior to the study. RESULTS: Patients (median age 35 years), of which 54.8% were females, were younger than the control cohort (median age 48 years). Patients had significantly higher NLR compared to the control group. Intensive care unit admitted patients had significantly higher platelet, WBC and neutrophil counts. The ICU patients' NLR was almost twice as of the non-intensive patients. The NLR value of 5.5 was found to be of high specificity (96.4%) and positive predictive value (91.4%) in diagnosing COVID-19. Furthermore, it had a very good sensitivity (86.4%) in predicting severe forms of disease, such as, ICU admission. CONCLUSION: Neutrophil-to-lymphocyte ratio is an important tool in determining the COVID-19 clinical status. This study further confirms the prognostic value of NLR in detecting severe infection, and those patients with high NLR should be closely monitored and managed.


Subject(s)
COVID-19/diagnosis , Lymphocyte Count , Neutrophils , Adult , Blood Cell Count , COVID-19/blood , Case-Control Studies , Female , Hospitalization , Humans , Intensive Care Units , Leukocyte Count , Male , Middle Aged , Platelet Count , Predictive Value of Tests , Prognosis , Retrospective Studies , SARS-CoV-2 , Saudi Arabia , Sensitivity and Specificity , Severity of Illness Index
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